Plerixafor Viatris (Plerixafor)
Generic CXCR4 Antagonist for Haematopoietic Stem Cell Mobilisation
Quick Facts About Plerixafor Viatris
Key Takeaways About Plerixafor Viatris
- Generic equivalent of Mozobil: Plerixafor Viatris contains the same active ingredient (plerixafor), at the same strength (20 mg/ml), in the same dosage form, and has the same indications as the originator product
- Always combined with G-CSF: Plerixafor is never used as monotherapy. It is administered alongside G-CSF (filgrastim, lenograstim, or pegfilgrastim) to maximise stem cell mobilisation prior to apheresis
- Rapid onset of mobilisation: CD34+ stem cells begin moving from bone marrow into peripheral blood within 4–9 hours of a subcutaneous dose, peaking at 9–14 hours, which determines the timing of apheresis
- For poor and predicted-poor mobilisers: Primarily used in patients with lymphoma or multiple myeloma who do not mobilise sufficient CD34+ cells (<20 cells/µL in peripheral blood) with G-CSF alone
- Administered by trained healthcare professionals: Given as a subcutaneous injection in a specialist haematology or transplant centre, typically 6–11 hours before each apheresis session over 2–4 consecutive days
What Is Plerixafor Viatris and What Is It Used For?
Plerixafor Viatris is a generic CXCR4 chemokine receptor antagonist that releases haematopoietic stem cells from the bone marrow into the peripheral blood. It is used in combination with G-CSF to enable stem cell collection (apheresis) before autologous stem cell transplantation in patients with lymphoma, multiple myeloma, or certain paediatric cancers. It contains the same active substance and is therapeutically equivalent to the originator product Mozobil.
High-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HSCT) is a key consolidation strategy for several haematological malignancies, including relapsed or high-risk non-Hodgkin lymphoma, Hodgkin lymphoma, and multiple myeloma. The procedure depends on the ability to harvest a sufficient number of the patient's own CD34+ haematopoietic stem cells, freeze them, and then reinfuse them after myeloablative conditioning. A well-recognised limiting step in this process is mobilisation: moving enough stem cells from the bone marrow into the bloodstream so that they can be collected by apheresis.
For many years, the standard mobilisation regimen has used G-CSF (granulocyte colony-stimulating factor, commonly filgrastim, lenograstim, or pegfilgrastim), either alone (steady-state mobilisation) or following chemotherapy (chemo-mobilisation). G-CSF stimulates bone marrow production of myeloid progenitors and gradually releases stem cells into the blood over several days. However, approximately 15–40% of patients fail to mobilise an adequate number of CD34+ cells with G-CSF alone. These patients are classified as "poor mobilisers" or "predicted poor mobilisers" and face delays, repeated collection attempts, or even inability to proceed to transplantation.
Plerixafor addresses this challenge through a distinct and complementary mechanism. It is a selective, reversible antagonist of the CXCR4 chemokine receptor expressed on haematopoietic stem and progenitor cells. Under normal conditions, the chemokine stromal cell-derived factor-1 alpha (SDF-1α, also called CXCL12), secreted by bone marrow stromal cells, binds to CXCR4 and anchors stem cells in the marrow microenvironment. By blocking this CXCR4/SDF-1α interaction, plerixafor rapidly releases CD34+ cells into the peripheral circulation, increasing circulating stem cell counts manyfold within hours of a single subcutaneous dose.
When plerixafor is combined with G-CSF, the two agents act synergistically: G-CSF expands the stem cell pool and primes mobilisation over 4–5 days, while plerixafor provides an acute, on-demand surge of CD34+ cells just before apheresis. Pivotal Phase III trials (AMD3100-3101 in multiple myeloma and AMD3100-3102 in non-Hodgkin lymphoma) demonstrated that this combination enables significantly more patients to reach their target cell dose and to do so with fewer apheresis sessions than G-CSF alone.
Plerixafor Viatris is a generic formulation marketed by Viatris, a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn (a division of Pfizer). As a generic, it has been assessed by regulatory authorities for pharmaceutical quality, equivalence of active substance, and bioequivalence to the reference product (Mozobil). It therefore offers the same clinical benefit and safety profile while supporting broader and more cost-effective access to plerixafor-based mobilisation regimens.
Approved Indications
Plerixafor Viatris is indicated, always in combination with G-CSF, for the following patient populations:
- Adults with lymphoma or multiple myeloma: To enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients whose cells mobilise poorly
- Children aged 1 year to under 18 years: With lymphoma or solid malignant tumours, to enhance stem cell mobilisation to the peripheral blood for collection and subsequent autologous transplantation, either after failing to collect enough stem cells or when predicted to fail
Pharmacology and Mechanism of Action
Plerixafor is a bicyclam compound with a molecular weight of 502.78 g/mol. It binds selectively and reversibly to the CXCR4 receptor, blocking the binding of SDF-1α (CXCL12) without itself activating the receptor. The CXCR4/CXCL12 axis is a key regulator of stem cell retention within the bone marrow niche; pharmacological blockade therefore releases CD34+ cells into the circulation.
Following subcutaneous injection, plerixafor reaches peak plasma concentrations within approximately 30–60 minutes. Mobilisation begins within 4–9 hours, with peak peripheral blood CD34+ counts typically occurring 9–14 hours after dosing — the basis for timing apheresis 6–11 hours post-dose. The elimination half-life is approximately 3–5 hours. Plerixafor is not significantly metabolised by cytochrome P450 enzymes and is eliminated primarily by the kidneys, with roughly 70% of the dose excreted unchanged in urine within 24 hours.
The reference product Mozobil was first approved by the US Food and Drug Administration (FDA) in December 2008 and by the European Medicines Agency (EMA) in July 2009. Plerixafor is included on the World Health Organization's Model List of Essential Medicines as a supportive therapy for autologous stem cell transplantation in specialist settings. Generic plerixafor products, including Plerixafor Viatris, became available in the European market following the expiry of original data exclusivity and patent protection, broadening access without altering the established clinical profile of plerixafor.
What Should You Know Before Using Plerixafor Viatris?
Before receiving Plerixafor Viatris, inform your transplant team about all medical conditions — particularly heart disease, kidney problems, high or low blood counts, a history of leukaemia, and any known drug allergies. Plerixafor is contraindicated in patients with hypersensitivity to the active substance and is not indicated for stem cell mobilisation in patients with leukaemia.
Contraindications
Plerixafor Viatris must not be used in the following situations:
- Hypersensitivity to plerixafor or to any of the excipients listed in the composition section. Hypersensitivity reactions, including anaphylaxis, have been reported in clinical use
- Patients with leukaemia who require stem cell mobilisation for autologous transplantation. The concern is that CXCR4 blockade may also mobilise leukaemic blasts into the peripheral blood, potentially contaminating the apheresis product and affecting transplant outcome
Warnings and Precautions
Talk to your haematologist, oncologist, or transplant physician before receiving Plerixafor Viatris if any of the following apply:
- Cardiovascular risk factors or pre-existing heart disease: Isolated cases of myocardial infarction have been reported in patients with significant cardiac risk factors who received plerixafor together with G-CSF. Baseline cardiac evaluation and close monitoring throughout mobilisation are recommended in these patients. Report chest pain, breathlessness, palpitations, or arm or jaw pain immediately
- Renal impairment: Plerixafor is cleared primarily by the kidneys. In patients with creatinine clearance (CrCl) ≤50 ml/min, the dose must be reduced by one-third. There is limited clinical experience in patients with severe renal impairment (CrCl <20 ml/min) or those on haemodialysis, and additional specialist judgement is required
- Leukocytosis: Both G-CSF and plerixafor raise white blood cell counts. Peripheral white blood cell and platelet counts should be monitored during mobilisation. Marked leukocytosis (>50–100 × 109/L) may warrant temporary interruption of mobilisation
- Thrombocytopenia: Reductions in platelet count may occur as a consequence of apheresis and/or plerixafor. Platelet monitoring is routine during stem cell collection, and platelet transfusions may be required to maintain safe thresholds
- Splenic enlargement or rupture: Although extremely rare, cases of splenic enlargement and rupture have been reported in patients receiving G-CSF with or without plerixafor. New or worsening upper-left abdominal or left shoulder-tip pain during mobilisation should be reported immediately as it may indicate splenomegaly or splenic rupture
- Vasovagal reactions: Orthostatic hypotension and syncope have been reported. Patients should remain under observation for 30–60 minutes after the first injection and inform staff of any lightheadedness, dizziness, or pre-syncopal sensations
- Tumour cell mobilisation: Because plerixafor mobilises haematopoietic cells broadly, the theoretical risk of mobilising residual tumour cells in patients with bone-marrow involvement cannot be entirely excluded. The transplant team will have considered this in recommending plerixafor
Swelling of the face, lips, tongue, or throat; widespread rash or hives; severe dizziness or fainting; sudden shortness of breath or difficulty breathing; chest pain, pressure, or tightness; pain radiating to the arm, jaw or back; or severe pain in the upper-left abdomen or left shoulder shortly after a plerixafor injection. These may indicate anaphylaxis, myocardial infarction, or splenic enlargement/rupture and require immediate evaluation.
Pregnancy and Breastfeeding
Plerixafor Viatris should not be used during pregnancy. There is no adequate clinical experience in pregnant women, and animal reproductive toxicity studies have demonstrated teratogenic and embryotoxic effects, including fetal malformations and reduced fetal weight. Women of childbearing potential must use effective contraception during treatment and for an appropriate period afterwards as advised by their physician.
Breastfeeding should be discontinued during treatment with Plerixafor Viatris. It is not known whether plerixafor or its metabolites are excreted in human milk. Given the potential for serious adverse reactions in nursing infants and the seriousness of the conditions being treated, the decision to stop breastfeeding or stop the medicine should be made together with the treating team, taking into account the benefit of therapy to the mother.
Plerixafor may also affect fertility. Both male and female patients of reproductive age should discuss fertility preservation options with their specialist before starting treatment, particularly because the wider transplant regimen (high-dose chemotherapy or radiotherapy) also carries substantial gonadotoxic risk.
Driving and Operating Machinery
Plerixafor may cause dizziness, fatigue, and — rarely — vasovagal reactions. Patients who experience these symptoms should not drive or operate heavy machinery until the symptoms resolve. Because mobilisation is carried out in specialised hospital or outpatient units, many patients will be under direct clinical supervision and may not need to drive on the same day as an injection.
Sodium Content and Excipients
Plerixafor Viatris contains less than 1 mmol sodium (23 mg) per dose and is therefore considered essentially "sodium-free". This information may be relevant for patients on a strictly controlled sodium diet, although the small volume of the injection is unlikely to have clinical importance.
How Does Plerixafor Viatris Interact with Other Drugs?
Plerixafor has a relatively low potential for drug–drug interactions because it is not metabolised by cytochrome P450 enzymes and is not a substrate or inhibitor of common drug transporters. Its most important clinical interaction is its required combination with G-CSF. Tell your transplant team about every medicine, supplement, or herbal product you are taking.
The pharmacokinetic profile of plerixafor minimises the risk of interactions mediated via hepatic metabolism. In vitro studies have shown that plerixafor is neither a substrate nor an inhibitor of the major CYP450 isoenzymes (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4) and is not a substrate for P-glycoprotein. No clinically significant interactions mediated by these pathways have been reported.
Because approximately 70% of a plerixafor dose is excreted unchanged by the kidneys, medicines that impair renal function or that compete with plerixafor for renal tubular elimination could theoretically alter its clearance. Concurrent use of nephrotoxic agents should be accompanied by careful renal monitoring, and plerixafor dose adjustment may be considered in the context of worsening renal function.
The most important "interaction" to be aware of is, in fact, deliberately therapeutic: plerixafor is always administered with G-CSF. Both agents increase circulating white blood cell counts and CD34+ cells, and their combined use is specifically designed to achieve synergistic mobilisation. White blood cell and platelet monitoring during combined therapy is standard.
Key Drug Interactions
| Drug / Class | Category | Effect | Recommendation |
|---|---|---|---|
| G-CSF (filgrastim, lenograstim, pegfilgrastim) | Colony-stimulating factor | Synergistic stem cell mobilisation; additive leukocytosis | Required combination; monitor WBC and platelet counts daily |
| Nephrotoxic agents (aminoglycosides, amphotericin B, cisplatin, NSAIDs) | Various | Potential reduction in plerixafor renal clearance; increased exposure | Monitor renal function; consider dose adjustment if CrCl ≤50 ml/min |
| Chemotherapy regimens (chemo-mobilisation) | Cytotoxic antineoplastic agents | Can be combined with G-CSF + plerixafor to enhance mobilisation | Timing must be precisely coordinated by the transplant team |
| Heparin / anticoagulants (used during apheresis) | Anticoagulant | Apheresis-related anticoagulation with overlapping thrombocytopenia | Monitor platelet counts closely; transfuse if thresholds fall |
| Live attenuated vaccines | Immunisation | Immunosuppression from the overall transplant pathway | Avoid live vaccines during mobilisation, conditioning, and early post-transplant period |
Minor and Theoretical Interactions
There are no known significant interactions between plerixafor and commonly used agents such as statins, antihypertensives, proton pump inhibitors, antidepressants, or anticonvulsants. However, because the overall treatment pathway includes high-dose chemotherapy and supportive care, a full medication review with a specialist pharmacist before mobilisation is strongly recommended. This helps identify any medications that need to be adjusted, substituted, or temporarily withheld — particularly those affecting renal function, marrow function, or clotting.
No formal drug–drug interaction studies have been conducted with plerixafor beyond its combined use with G-CSF. Plerixafor is neither a substrate nor an inhibitor of CYP450 enzymes and is not a P-glycoprotein substrate. In populations on multiple medications (common in lymphoma and myeloma patients following several prior lines of therapy), a structured medication reconciliation at the time of mobilisation planning is a practical way to reduce unexpected issues.
What Is the Correct Dosage of Plerixafor Viatris?
The recommended adult dose of Plerixafor Viatris is 0.24 mg/kg body weight (or a fixed 20 mg dose in patients weighing >83 kg) given as a subcutaneous injection 6–11 hours before each apheresis session. The dose is reduced in renal impairment. Treatment is usually given for 2–4 consecutive days, up to a maximum of 7 days, in combination with G-CSF.
Plerixafor Viatris is administered as part of a multi-day mobilisation programme. G-CSF is started first, typically on days 1–4 of the cycle, to prime the bone marrow. Plerixafor is then added on the evening of day 4 (or the evening before each apheresis session), so that peak peripheral CD34+ counts coincide with the apheresis the next morning. Apheresis is performed daily until the target CD34+ cell dose is collected, usually over 2–4 sessions.
Adults
Standard Adult Dosage (normal renal function)
Dose: 0.24 mg/kg body weight per day (a fixed 20 mg dose is an acceptable alternative in patients weighing up to 83 kg)
Route: Subcutaneous injection
Timing: 6 to 11 hours before the start of each apheresis session
Duration: 2–4 consecutive days (up to a maximum of 7 days)
Notes: Body weight should be measured within 1 week before the first dose. Continue daily injections until the target CD34+ cell yield (typically ≥2–5 × 106 CD34+ cells/kg) has been collected.
Renal Impairment (CrCl ≤50 ml/min)
Dose: Reduced to 0.16 mg/kg body weight per day (approximately a one-third reduction)
Maximum daily dose: 27 mg/day regardless of body weight
Notes: Limited data in patients with CrCl <20 ml/min or on dialysis. In such patients, dosing must be individualised by a specialist transplant team with close monitoring of renal function and clinical response.
Children (1 Year to Under 18 Years)
Paediatric Dosage
Dose: 0.24 mg/kg body weight per day
Route: Subcutaneous injection
Timing: 6 to 11 hours before apheresis
Duration: Up to 4 consecutive days (maximum 7 days)
Notes: Safety and efficacy have not been established in children below 1 year of age. Paediatric dosing is strictly weight-based; injection volume and site should be adapted to the child's size, and parents or carers should be actively involved in preparing the child for each injection.
Elderly Patients
No specific age-based dose adjustment is recommended. However, renal function declines with age, and older adults are more likely to have cardiovascular comorbidities. Plerixafor Viatris should therefore be dosed according to creatinine clearance, with careful cardiac and haematological monitoring during mobilisation in elderly patients.
How Is Plerixafor Viatris Given?
Plerixafor Viatris is administered by a trained healthcare professional as a subcutaneous injection into the abdomen, upper arm, or thigh. Injection sites should be rotated to minimise local irritation. The typical sequence of a mobilisation cycle is:
- Days 1–4 (approximately): G-CSF is initiated at a standard mobilisation dose (commonly 10 µg/kg/day subcutaneously) to expand and begin mobilising the stem cell pool
- Evening of Day 4 (or the evening before each apheresis): Plerixafor Viatris is injected subcutaneously, 6–11 hours before the planned apheresis session the next day
- Day 5 onwards (morning): Apheresis is performed to collect CD34+ cells from the peripheral blood
- Repeat: G-CSF and plerixafor are repeated daily in parallel with apheresis until the target cell dose has been collected
Missed Dose
Because Plerixafor Viatris is given in a hospital or specialist outpatient setting on a pre-planned schedule, truly missed doses are rare. If a scheduled injection is delayed or missed, the transplant team will reassess the timing relative to apheresis: typically, the dose is given as soon as possible while preserving the 6–11 hour interval before the next collection, or the apheresis timing is adjusted. Patients should never attempt to self-administer or adjust the timing of doses without explicit guidance from the team.
Overdose
Clinical experience with plerixafor overdose is limited. In dose-escalation studies with healthy volunteers, doses up to 0.48 mg/kg were evaluated. Dose-limiting adverse effects at higher doses included gastrointestinal symptoms (nausea, vomiting, diarrhoea), orthostatic hypotension, and vasovagal reactions. There is no specific antidote. Management is supportive, including cardiovascular monitoring, maintenance of circulating volume, and symptomatic treatment of gastrointestinal effects.
| Patient Group | Dose | Route | Special Considerations |
|---|---|---|---|
| Adults (normal renal function) | 0.24 mg/kg/day (or 20 mg fixed if ≤83 kg) | Subcutaneous | Weigh patient within 1 week; 6–11 h before apheresis |
| Adults (CrCl ≤50 ml/min) | 0.16 mg/kg/day | Subcutaneous | Max 27 mg/day; monitor renal function closely |
| Children (1–17 years) | 0.24 mg/kg/day | Subcutaneous | Weight-based dosing; paediatric haematology supervision |
| Elderly | As per adult dosing, adjusted for renal function | Subcutaneous | Baseline cardiac assessment; monitor during mobilisation |
| Severe renal impairment (CrCl <20 ml/min) or dialysis | Individualised | Subcutaneous | Limited data; specialist decision and intensive monitoring |
What Are the Side Effects of Plerixafor Viatris?
The most common side effects of Plerixafor Viatris include gastrointestinal symptoms (diarrhoea, nausea, vomiting), injection site reactions, headache, dizziness, fatigue, and mild musculoskeletal pain. Serious but less common effects include hypersensitivity reactions (including anaphylaxis) and, rarely, myocardial infarction in patients with pre-existing cardiac risk factors.
Like all medicines, Plerixafor Viatris can cause side effects, although not everyone will experience them. As a generic medicine, it shares the established safety profile of the reference product Mozobil, which has been characterised in large Phase III trials (AMD3100-3101 and AMD3100-3102) and extensive post-marketing surveillance across Europe, North America, and Asia. Most adverse events are mild to moderate in intensity and resolve quickly after the end of mobilisation.
Because plerixafor is always given together with G-CSF and in patients recovering from intensive prior therapy, some symptoms reported during mobilisation reflect the underlying disease, G-CSF, or the apheresis procedure itself rather than plerixafor specifically. Your transplant team will assess any symptoms in this wider context and adjust treatment accordingly.
Very Common (affects more than 1 in 10 people)
- Diarrhoea
- Nausea
- Injection site reactions (redness, irritation, pain, swelling, pruritus)
- Anaemia (particularly in paediatric patients)
Common (affects up to 1 in 10 people)
- Headache
- Dizziness
- Fatigue and general malaise
- Insomnia and sleep disturbances
- Flatulence (intestinal gas)
- Constipation
- Dyspepsia (indigestion)
- Vomiting
- Abdominal pain, bloating, or discomfort
- Dry mouth
- Oral hypoaesthesia (numbness around the mouth)
- Hyperhidrosis (excessive sweating)
- Generalised erythema (skin redness)
- Arthralgia (joint pain)
- Musculoskeletal pain, including bone pain
Uncommon (affects up to 1 in 100 people)
- Allergic reactions (rash, urticaria, periorbital swelling)
- Anaphylactic reactions, including anaphylactic shock
- Abnormal dreams and nightmares
- Myocardial infarction (in patients with cardiac risk factors)
- Vasovagal reactions and orthostatic hypotension
Rare and Post-Marketing Reports
- Severe gastrointestinal events (severe diarrhoea or vomiting)
- Splenic enlargement (splenomegaly)
- Splenic rupture (very rare, reported mainly with G-CSF)
- Dyspnoea (shortness of breath) and hypoxia
- Hyperleukocytosis requiring treatment interruption
Cardiac Events
In Phase III clinical trials, uncommon myocardial infarction events were reported in patients with pre-existing cardiovascular risk factors who received plerixafor in combination with G-CSF. A causal role for plerixafor has not been definitively established, given the complex clinical background (prior chemotherapy, G-CSF, and established cardiac disease). Nonetheless, a careful cardiac history should be taken before mobilisation in all patients with known risk factors, and any new chest pain, pressure, tightness, breathlessness, or arm or jaw discomfort during mobilisation requires immediate evaluation.
Leukocytosis (High White Blood Cell Count)
A rise in total white blood cell count is an expected pharmacodynamic effect of G-CSF plus plerixafor. Counts typically return to normal within days of stopping mobilisation. Clinically meaningful hyperleukocytosis is managed by temporarily pausing mobilisation and adjusting the next dose. Regular blood counts are performed throughout mobilisation; your team will explain the results and any required changes in plan.
Apheresis-Related Thrombocytopenia
Each apheresis session can reduce platelet count; repeated sessions during mobilisation may lead to transient thrombocytopenia. Platelet counts are monitored before each session. If counts fall below safe thresholds, platelet transfusion or a delay in further apheresis may be required. This is a well-recognised feature of stem cell collection rather than a specific toxicity of plerixafor alone.
Paraesthesia and Sensory Symptoms
Tingling sensations, numbness, and other minor sensory symptoms are common in patients with haematological malignancies, often reflecting prior chemotherapy rather than plerixafor. Clinical trial data suggest plerixafor does not significantly increase the frequency of these symptoms compared with G-CSF alone, but new or worsening neurological symptoms should always be reported to your care team.
Reporting suspected side effects after market authorisation is important for the continuous monitoring of the benefit–risk balance of the medicine. Patients and healthcare professionals can report adverse reactions through national pharmacovigilance schemes, such as the FDA MedWatch programme (US), the MHRA Yellow Card Scheme (UK), the HPRA (Ireland), the TGA (Australia), or the EMA EudraVigilance system (EU), as well as through the Viatris medical information service.
How Should You Store Plerixafor Viatris?
Plerixafor Viatris vials should be stored at room temperature (below 30°C), in their original carton, out of the sight and reach of children. Do not freeze, do not use after the expiry date, and discard any unused solution after opening.
Plerixafor Viatris is supplied as a sterile solution for injection in single-use glass vials. In most countries, storage and handling are the responsibility of hospital pharmacy and ward staff rather than the patient, because the medicine is used in specialist centres under professional supervision. The following storage principles apply:
- Temperature: Store at room temperature, below 30°C. Do not freeze
- Packaging: Keep vials in the outer carton until use to protect against physical damage
- Light protection: No specific light-protection requirement during storage; the solution should nonetheless be inspected for discolouration before use
- Visual inspection: Before administration, the solution must be clear and colourless to slightly yellow, with no visible particles. Discard if discoloured, turbid, or containing particulate matter
- After opening: Because the product does not contain a preservative, any withdrawn solution should be used immediately. Discard unused portions in the same session
- Expiry date: Do not use after the expiry date printed on the carton and vial label. The expiry date refers to the last day of the stated month
- Disposal: Any unused medicine or empty vials should be disposed of according to local pharmaceutical waste regulations. Do not flush down drains or dispose of via household waste
- Out of reach of children: Keep all medicines out of the sight and reach of children at home, in the extremely unlikely event that vials are stored outside a hospital setting
What Does Plerixafor Viatris Contain?
Each vial of Plerixafor Viatris contains 24 mg of plerixafor in 1.2 ml of solution (concentration: 20 mg/ml). The inactive ingredients are sodium chloride, hydrochloric acid and/or sodium hydroxide for pH adjustment, and water for injections.
Active Ingredient
The active substance is plerixafor. Each millilitre of solution for injection contains 20 mg of plerixafor, and each single-use vial contains 1.2 ml of solution (24 mg of plerixafor per vial). Plerixafor is a symmetric bicyclam molecule (chemical name: 1,1′-[1,4-phenylenebis(methylene)]bis[1,4,8,11-tetraazacyclotetradecane]) with a molecular weight of 502.78 g/mol. It is a selective, reversible antagonist of the CXCR4 chemokine receptor.
As a generic medicine, Plerixafor Viatris contains the same active substance in the same strength and pharmaceutical form as the reference product Mozobil, and has been assessed by regulators to ensure pharmaceutical equivalence and bioequivalence. The clinical efficacy and safety data for plerixafor therefore apply directly to Plerixafor Viatris.
Excipients (Inactive Ingredients)
- Sodium chloride: Adjusts tonicity so the solution is isotonic and comfortable to inject
- Hydrochloric acid (concentrated): Used for pH adjustment
- Sodium hydroxide: Used for pH adjustment
- Water for injections: Solvent
Plerixafor Viatris does not contain preservatives. The vial is intended for single use; any unused solution must be discarded. The formulation is free of animal-derived excipients and does not contain lactose, gluten, or common allergenic constituents.
Appearance and Packaging
Plerixafor Viatris is a clear, colourless to slightly yellowish solution for injection, supplied in a Type I glass vial with a latex-free elastomeric stopper and a sealed aluminium flip-off cap. Each carton contains one single-use vial with 1.2 ml of solution, providing a full 24 mg dose of plerixafor. The label includes product name, strength, batch number, and expiry date.
Manufacturer and Marketing Authorisation Holder
Plerixafor Viatris is marketed by Viatris Limited (and affiliated national Viatris entities across Europe and other regions). Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, with a broad portfolio of generic, branded, and complex medicines, including several specialist oncology and haematology products. The detailed name and address of the marketing authorisation holder and the manufacturer for each country are provided in the official national product information and package leaflet supplied with the medicine.
Frequently Asked Questions About Plerixafor Viatris
Plerixafor Viatris is a generic version of the originator product Mozobil. Both contain the same active substance (plerixafor) at the same concentration (20 mg/ml solution for injection) and are used in the same way for the same indications. To be approved as a generic, Plerixafor Viatris must demonstrate pharmaceutical equivalence and bioequivalence to Mozobil, ensuring the body handles it in essentially the same way. The clinical efficacy and safety evidence gathered for plerixafor therefore applies to both products.
Plerixafor Viatris is used, in combination with G-CSF, to mobilise haematopoietic stem cells from the bone marrow into the peripheral blood so they can be collected by apheresis for autologous stem cell transplantation. It is indicated for adults with lymphoma or multiple myeloma whose stem cells mobilise poorly with G-CSF alone, and for children aged 1 to under 18 years with lymphoma or solid tumours in the same clinical context. It is not used on its own or for conditions outside the stem cell mobilisation setting.
Plerixafor blocks the CXCR4 receptor on haematopoietic stem cells. Normally, the chemokine SDF-1α (CXCL12), produced by bone marrow stromal cells, binds to CXCR4 and keeps stem cells anchored in the marrow. By interrupting this interaction, plerixafor allows stem cells to be released into the blood, where they can be collected by apheresis. When used with G-CSF, which has expanded the stem cell pool over several days, plerixafor provides a rapid additional surge of CD34+ cells just before collection, giving higher stem cell yields than either agent alone.
Plerixafor and G-CSF act through different, complementary mechanisms. G-CSF stimulates the bone marrow to produce more stem cells and gradually releases them over several days, while plerixafor provides a rapid, on-demand release by blocking the receptor that holds stem cells in the marrow. Used together, they achieve significantly higher CD34+ cell yields than either agent alone, which is essential for a successful autologous transplant. Plerixafor alone would release only the stem cells already in the marrow, giving insufficient yields; G-CSF alone fails to reach adequate mobilisation in a substantial minority of patients.
Plerixafor is almost always administered by a healthcare professional in a specialist haematology or transplant unit, because it forms part of a complex mobilisation and apheresis programme requiring close monitoring of blood counts and clinical response. In some centres, selected experienced patients may be trained to self-inject under the guidance of the transplant team. This is an individual decision made by the treating specialist, and most patients will receive the injection in hospital or in a closely supervised outpatient setting.
If the target CD34+ cell dose cannot be collected, mobilisation with G-CSF plus plerixafor can be extended for additional days up to the maximum recommended duration. If sufficient cells still cannot be obtained, the transplant team will consider alternative strategies: a repeat mobilisation at a later date with a modified regimen, chemo-mobilisation with or without plerixafor, or, in some cases, a bone marrow harvest under general anaesthesia. The overall transplant plan may also be reassessed by the multidisciplinary team.
Plerixafor Viatris can be used in patients with kidney problems, but the dose must be adjusted. Because plerixafor is cleared primarily by the kidneys, patients with moderate to severe renal impairment (creatinine clearance ≤50 ml/min) should receive 0.16 mg/kg/day instead of the standard 0.24 mg/kg/day, with a maximum of 27 mg/day. Clinical experience in patients with very severe renal impairment (CrCl <20 ml/min) or on dialysis is limited, so an individualised approach with careful monitoring by the transplant team is required.
No. Because Plerixafor Viatris is an approved generic of Mozobil with the same active substance, strength, dosage form, and route of administration, its clinical effect is expected to be equivalent to the reference product. Generic medicines are assessed by regulators for pharmaceutical quality and bioequivalence, and the published clinical efficacy and safety data for plerixafor apply directly to all approved plerixafor products. Your transplant team will explain any practical differences in packaging or presentation.
References
- European Medicines Agency (EMA). Plerixafor products – Summary of Product Characteristics and European Public Assessment Reports. EMA, updated 2024.
- US Food and Drug Administration (FDA). Plerixafor (Mozobil) injection – Prescribing Information and Orange Book entries for approved generics. FDA, 2023–2024.
- DiPersio JF, Stadtmauer EA, Nademanee A, et al. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009;113(23):5720–5726.
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Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, a multidisciplinary group of licensed healthcare professionals with expertise in haematology, oncology, clinical pharmacology, and stem cell transplantation. Our aim is to provide accurate, evidence-based information that is useful for patients, carers, and non-specialist clinicians.
iMedic Medical Editorial Team — specialists in haematology and clinical pharmacology with practical experience in stem cell mobilisation, apheresis, and transplant supportive care.
iMedic Medical Review Board — an independent panel of medical experts who verify accuracy, completeness, and adherence to international guidelines (EBMT, ASTCT, NICE, EMA, FDA, WHO).
This article follows the GRADE evidence framework and is based on systematic reviews, randomised controlled trials, and international clinical guidelines. Content is independently produced with no commercial funding or pharmaceutical industry sponsorship. Last reviewed: .